Cue Biopharma Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases

In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed

Proof-of-concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401

BOSTON, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, today announced preclinical safety and tolerability data that further supports the preclinical profile of CUE-401, the Company’s lead autoimmune asset.

“We are very encouraged with this preclinical data, which demonstrated that CUE-401 was well tolerated, and no adverse events were observed,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “Data generated from these preclinical studies represent an important addition to the growing evidence supporting the potential of CUE-401 as a first-in-class bifunctional tolerogenic agent for the treatment of autoimmune disease. We look forward to sharing further scientific data and details on the planned investigational new drug (IND) filing for CUE-401 in the upcoming months.”

Study design and key data highlights include:
Two separate non-GLP studies in mice and non-human primates (NHPs) assessed the safety and tolerability of CUE-401 using a step-up dosing schedule, where animals successively received higher doses of CUE-401, weekly. CUE-401 was administered intravenously.

Murine Study (n=24, 12 males, 12 females)

• Animals received escalating doses of CUE-401 at 1 mg/kg, 3 mg/kg, and 10 mg/kg
• All dose levels were well tolerated, and no adverse events were observed
  
  

NHP Study (n=6, 3 males, 3 females)

• Core study: Animals received escalating doses of CUE-401 at 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg
• All dose levels were well tolerated in the core study with no adverse observations
• Follow-up dosing: Following observed tolerability and safety in the core study, animals were given an additional dose of CUE-401 a week later at 1 mg/kg (n=2 animals, 1 female, 1 male) or 3 mg/kg (n=4 animals, 2 male, 2 female)
• Repeat dosing of CUE-401 at 1 mg/kg was better tolerated than the repeat dosing at 3 mg/kg
  
  

About CUE-401
CUE-401 is a novel bifunctional therapeutic that incorporates an innovative TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic. The design of CUE 401 was inspired by Nobel Prize winning science in 2025 for the role of IL-2 and TGF-beta as essential components in helping establish immune tolerance by regulating FOXP3 signaling. CUE-401 is designed to promote immune regulation and tolerance by three complementary mechanisms: 1. Direct regulation of proinflammatory mechanisms by TGF-beta, 2. Expansion of existing Tregs by IL-2, and 3. Conversion of FOXP3- conventional CD4+ T cells into FOXP3+ induced Tregs through the coordinated provision of TGF-beta and IL-2 signals, both of which are required for the de novo induction of FOXP3 expression.

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically both as a regulator of proinflammatory mechanisms, and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance. It is a highly innovative, tolerogenic bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.